Kornimate/medical-research-clean huggingface dataset:
pyrotinib combined with trastuzumab for maintenance therapy after first-line th (p) therapy for her2+abc

Conditions: HER2-positive Breast Cancer

Summary: a single-arm, multicenter, real-world observational study of pyrotinib combined with trastuzumab for maintenance therapy after first-line th (p) therapy for her2+abc

in this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached sd, cr or pr, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles; single-arm, multicenter, real-world observational studies using endocrine therapy + pyrrotinib + trastuzumab in patients with hr+, and maintenance therapy after first-line th (p) therapy for cns events (if non-cns recurrent, progressive events occur and the investigator decides to change the follow-up regimen). to evaluate the effect of pyrrotinib combined with trastuzumab in maintaining treatment phase delay/reduction of brain metastases after first-line th (p) therapy for advanced breast cancer with her-2 positivity, the incidence of first progression of brain metastases was used as the primary endpoint.

Eligibility criteria:
inclusion criteria: 1. age: 18-70 years old, female; 2. pathological examination confirmed her-2 positive invasive breast cancer; her2-positive is defined as \>10% of tumor cells with an immunohistochemical (ihc) score of 3+ or in situ hybridization (ish) results as her2 gene amplification. a positive her2 should be confirmed by the pathology department of the participating center of this study.) imaging examination confirmed recurrent/metastatic breast cancer; 3. patients with recurrence or metastasis more than 1 year after trastuzumab treatment, or newly diagnosed stage iv breast cancer; 4. ecog score is 0-1; 5. expected survival ≥6 months; 6. normal function of major organs; 7. 1) blood routine • anc≥1.5×109/l; • plt≥90×109/l; • hb≥90 g/l; 2) blood biochemistry • tbil≤1.5×uln; • alt and ast≤2 x uln; for patients with liver metastases, alt and ast≤5× uln; • bun and cr ≤ 1.5×uln and creatinine removal rate ≥ 50 ml/min; 3) heart color ultrasound • lvef≥50%; 8. the researcher believes that the subject is likely to benefit; 9. voluntarily participate in the study and sign the informed consent exclusion criteria: 1. head mri or head ct confirms the presence of brain metastases; 2. have multiple factors affecting oral medication (history of gastrointestinal surgery, inability to swallow, chronic diarrhea, intestinal obstruction); 3. study patients allergic to drugs and excipients; 4. suffering from mental illness or psychotropic substance abuse, unable to cooperate; 5. pregnant or lactating women; 6. participated in clinical trials within 4 weeks; 7. participants considered unsuitable for inclusion by the researchers.
characterization of recently deployed veterans

Conditions: Posttraumatic Stress Disorder

Summary: this study is a retrospective chart review of recently deployed veterans who served during the iraq conflicts and were seen at the tvamc in the outpatient primary care outpatient clinic that was recently set-up for newly returning veterans since its inception through july 1, 2005. identical data will be collected on non-combat veterans that were seen in other primary care clinics at the tuscaloosa va medical center during june 2004 and july 1, 2005. this information will be used for comparison with the iraqi veterans group. the data will be retrieved from a computerized list of these patients. charts will then be examined to determine sociodemographic, medical, psychiatric, and health care utilization characteristics.

the information will also be used internally at the tvamc to better define treatment needs and also used in presentations and possible publications at professional meetings and in journals. while this study is designed to be hypothesis generating for large prospective studies, we hypothesize that a majority of the recently deployed veterans who served in the iraq conflict are in need of basic primary health care needs for illnesses that are common place among patients within this age group, except for a higher than expected prevalence of mood and anxiety disorders compared to usual primary care treatment-seeking populations. this study is a retrospective chart review of recently deployed veterans who served during the iraq conflicts and were seen at the tvamc in the outpatient primary care outpatient clinic that was recently set-up for newly returning veterans since its inception through july 1, 2005. identical data will be collected on non-combat veterans that were seen in other primary care clinics at the tuscaloosa va medical center during june 2004 and july 1, 2005. this information will be used for comparison with the iraqi veterans group. the data will be retrieved from a computerized list of these patients. charts will then be examined to determine sociodemographic, medical, psychiatric, and health care utilization characteristics.

Eligibility criteria:
inclusion criteria: * male or female patients, any race or ethic origin, at least 19 years of age * patients must have been seen by a provider in the outpatient primary care clinic that has recently been set-up to serve recently deployed veterans who served during the iraq conflict exclusion criteria: * patients who did not serve during the iraq conflict

Keywords: ptsd veterans deployed
a multicenter real world study of kanglaite for cancer cachexia

Conditions: Cancer Cachexia

Summary: a prospective, multi-center real-world study of the effectiveness and safety of kanglaita injection/capsule in chinese patients with cancer cachexia

this is a large national-based prospective, multi-center real-world observational study. cancer cachexia patients scheduled for sequential treatment with kanglaite injection and capsule between august 2018 and march 2020 at 640 participating hospitals will be recruited to evaluate the effectiveness and safety of kanglaite.

Eligibility criteria:
inclusion criteria: patients with pathological or cytological diagnosis of lung, liver, pancreatic or stomach cancer; patients scheduled to receive kanglaite injection for 7 or more days, followed by kanglaite capsule for 14 or more days; patients willing to participate in this study and provide written informed consent. exclusion criteria: none

Keywords: kanglaita injection/capsule cancer cachexia real-world evidences overall survival
can pretreatment mri be used to predict intra-arterial chemotherapy response in retinoblastoma?

Conditions: Retinoblastoma

Summary: retinoblastoma is the most frequent intraocular tumor in children and represents 6% of all pediatric cancers before the age of 5 years-old. the outcome is now excellent with 95 to 97% of 5-years survival rate. conservative treatments are being more and more used, and intra arterial chemotherapy is one of the adjuvant treatments proposed to the children. the treatment is efficient in most cases, but a small proportion of children will have an early progression after treatment. mri is used for the diagnosis of retinoblastoma. we aim to find prognostic factors using dynamic contrast-enhanced magnetic resonance imaging (dce-mri) for early identification of children response to intra arterial chemotherapy.


Eligibility criteria:
inclusion criteria: * grade b to d retinoblastoma * prescription of intra arterial chemotherapy exclusion criteria: * none
pet/mri study on the neurological mechanism of rtms treatment for heroin addiction

Conditions: Heroin Addiction; Relapse

Summary: heroin addiction is a serious problem and the relapse rate of existing treatment methods is extremely high. recently, international journals such as science reported that repetitive transcranial magnetic stimulation (rtms) can reduce the craving of addicts, alleviate depression and anxiety symptoms, and is expected to become an effective treatment. our preliminary experiment using rtms to stimulate the left dorsolateral prefrontal cortex of heroin addicts also showed similar effects, however, the mechanism is unclear. previously, the investigators found that the functional connectivity between left executive control network and default mode network was negatively correlated relapse behavior, while the functional connectivity between salience network and default mode network was positively correlated with relapse behavior. studies have shown that dopamine dysfunction in addicts and brain metabolism is the biological basis of network connectivity. it suggests that elucidating the relationship between the characteristics of large brain network connectivity and the level of dopamine receptor and relapse behavior in addicts is hopeful to further understand the neurological mechanism of rtms treatment for addiction. in this project, the investigators intend to observe the changes of brain network connectivity, glucose metabolism and dopamine d2 receptor before and after rtms treatment in addicts from the perspective of large brain network by combining pet/mri with psychobehavioral approach. the relationship between rtms and relapse behavior will be deeply analyzed to provide scientific basis for the development of effective treatment programs.


Eligibility criteria:
inclusion criteria for heroin-dependent participants: * clinical diagnosis of heroin addiction * have been receiving treatment in a methadone maintenance treatment program for no less than 6 months * have been on a stable dose for at least 1 month before entering the study * right-handed inclusion criteria for healthy control participants: * clinical diagnosis of healthy control * right-handed exclusion criteria for all participants: * current or past psychiatric illness other than heroin and nicotine dependence * neurological signs and/or history of neurological disease * history of head trauma * history of cardiovascular or endocrine disease * current medical illness or recent medicine use * presence of magnetically active objects in the body * claustrophobia or any other medical condition that would preclude the participant from lying in the pet/mri scanner for approximately 40 min.

Keywords: repetitive transcranial magnetic stimulation functional magnetic resonance imaging positron emission tomography
initial double sequential external defibrillation in out of hospital cardiac arrest

Conditions: Cardiac Arrest; Out-Of-Hospital Cardiac Arrest; Ventricular Fibrillation

Summary: double sequential external defibrillation (dsed) represents an alternative treatment of refractory ventricular fibrillation (rvf) in out-of-hospital cardiac arrest (ohca). the procedure consists of two defibrillators that administer shocks at the same time. currently, the procedure is not initiated before at least three failed attempts with one defibrillator. this can delay the potential benefits of establishing dsed earlier in the treatment. studies have shown that early defibrillation is crucial for survival in ohca patients, and in 2022, a clinical trial showed that survival in patients treated with dsed was higher compared to standard treatment. the effect of initiating ohca treatment is unknown. the dualdefib trial seeks to investigate if treating ohca patients with dsed as an initial treatment will increase survival and provide improved neurological outcome.

the project is investigator-initiated, prospective, two-group randomized controlled trial (rct). prior to the rct, a pilot feasibility trial of 3-4 months will be performed, including three ambulance bases in mid-norway. all ohca patients will be included until validity and feasibility of the study is accomplished. the pilot study will be followed by the rct. outcome measurements in the rct are aimed to be the same as in the pilot study. ambulance bases will be randomized to either dsed or standard procedure for six months before crossover with the other treatment for six months. ambulances included in the project will carry two defibrillators. both defibrillators will be established for initial defibrillation with dsed in ohca patients. the pads are placed in anterior-lateral position (standard placement) and anterior-posterior position (over sternum and beneath left scapula). shocks are administered in rapid succession with less than one second apart. all other treatment will be according to existing guidelines. the included patients are ohca patients with age over 18 years presenting with a shockable rhythm. excluded patients are patients with obvious or suspected pregnancy, incarcerated patients or patients with no-resuscitation order. the patients that meet the inclusion criteria will be registered by the ambulance personnel through a secure webpage. primary outcome is survival to hospital admission. secondary outcomes are survival to hospital discharge, 30 days, 90 days and 1 year survival, in addition to neurological status. patients from the pilot will be included in the rct intervention group.

Eligibility criteria:
inclusion criteria: * patients with out of hospital cardiac arrest presenting with a shockable rhythm exclusion criteria: * age below 18 years * obvious or suspected pregnancy * incarcerated patients * preexisting do-not-resuscitate order

Keywords: double defibrillation cardiopulmonary resuscitation
individualised versus standard care for breast cancer patients at high-risk for chemotherapy-induced nausea and vomiting the iliad study

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate whether adding olanzapine 5mg to standard antiemetic medication can significantly reduce chemotherapy-induced nausea and vomiting in breast cancer patients receiving emetogenic chemotherapy regimens such as anthracycline with cyclophosphamide-based chemotherapy and platinum-based chemotherapy. to help clinicians prescribe antiemetic medications in a more patient-centered, evidence-based and cost-effective manner, we've developed the world's first validated risk-stratification tool for chemotherapy-induced nausea and vomiting (cinv) and because of this, it is now possible to perform a trial of personalized precision antiemetic therapy for breast cancer patients. despite widespread antiemetic use, chemotherapy-induced nausea and vomiting (cinv) remains among the most feared and expected side effects of chemotherapy for breast cancer. inadequately controlled cinv can significantly reduce a patient's quality of life, impair functional activity, lead to chemotherapy dose delays and reductions, and even discontinuation of treatment. the merit of current antiemetic medications is based on their ability to control chemotherapy-induced vomiting, but not necessarily nausea, and nausea is the major issue for breast cancer patients. with olanzapine demonstrating significant promise in preventing acute and delayed nausea, the investigators are proposing to evaluate guideline-recommended aprepitant-based triple regimen compared to the same regimen plus olanzapine (5 mg) for patients at high personal risk for cinv. for patients at low personal risk for cinv the investigators will also evaluate guideline-recommended double antiemetic regimen compared to the same regimen plus olanzapine (5 mg).


Eligibility criteria:
inclusion criteria: * newly diagnosed invasive breast cancer (stage i-iii) scheduled to receive neo/adjuvant anthracycline/cyclophosphamide or platinum-based chemotherapy * ≥18 years * able to provide consent and complete all study-related diaries and questionnaires. exclusion criteria: * received previous chemotherapy * symptoms of nausea or vomiting at baseline * on chronic antiemetic therapy (e.g. metoclopramide); on daily long term oral steroids prior to chemotherapy * allergic or having a medical condition that makes the administration of olanzapine, aprepitant, 5-ht3 antagonists or dexamethasone contraindicated * uncontrolled diabetes * known/documented medical/psychiatric illness that would interfere with patients' ability to complete the diary and study-related questionnaires.

Keywords: breast cancer breast carcinoma breast tumors chemotherapy antiemetic effects antiemetic drugs drug therapy
the pivotal study of the aptus endovascular aaa repair system

Conditions: Abdominal Aortic Aneurysms (AAA)

Summary: a prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the aptus endovascular aaa repair system compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (aaa).

the historical group is the open surgical repair procedures (n=323) in the lifeline foundation (now american vascular association foundation).

Eligibility criteria:
inclusion criteria: * infrarenal aaa with a maximum diameter ≥ 4.5 cm. * infrarenal aaa with at least 12 mm length of non-aneurysmal proximal neck. * infrarenal aaa with a proximal neck internal diameter between 19-29 mm. * infrarenal aaa with an internal diameter at the aortic bifurcation ≥ 18 mm. * infrarenal aaa with an angle of ≤ 60° relative to the long axis of the aneurysm. * bilateral iliac artery distal fixation sites ≥ 10 mm in length. * bilateral iliac arteries with an internal diameter between 9 and 20 mm. * bilateral femoral/iliac arteries with morphology compatible with standard vascular access techniques and vessel size must accommodate a 16f (5.3 mm) or 18f (6.0 mm) delivery system. exclusion criteria: * myocardial infarction within past 10 weeks. * active systemic infection. * ruptured or leaking aaa. * mycotic or inflammatory aaa. * genetic connective tissue disorders (e.g., marfans or ehlers-danlos syndromes). * concomitant taa or thoracoabdominal aortic aneurysms. * requires emergent aaa surgery. * previous aaa repair. * patients with a body habitus that would prevent imaging required by the study. * patient has significant comorbid conditions that pose undue risk of general anesthesia or endovascular surgery. * patient requires additional planned major procedure at the time of aaa repair or within 30 days before or after aaa repair. * dialysis dependent renal failure or creatinine \> 2.5 mg/dl. * allergy to or intolerance of radiopaque contrast agents. * patients with a known sensitivity or allergy to implant materials. * patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure. * patients with history of bleeding diathesis or hypercoagulable condition. * patients with thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180°) continuous coverage of the vessel circumference in the intended seal zone. * patients with irregular shaped calcification and/or plaque that may compromise the fixation and sealing at the proximal or distal implantation sites.
the assessment of survival after in-hospital cardiac arrest for 2 years in tertiary hospital

Conditions: Cardiac Arrest

Summary: define the frequency and survival pattern of cardiac arrests in relation to the hospital day of event and etiology of arrest.

define the frequency and survival pattern of cardiac arrests in relation with event and etiology of arrest. investigators aims to evaluate the outcome of in-hospital cardiac arrests, focusing on the relationship between etiology and outcome.

Eligibility criteria:
inclusion criteria: * cases where the cardiac arrest team is called exclusion criteria: * lack of data records of patients

Keywords: in-hospital cardiac arrest
study evaluating the safety and efficacy of clonicel® to treat children and adolescents with attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to determine whether clonicel® (clonidine hcl sustained release) is a safe and effective treatment for children and adolescents with attention deficit hyperactivity disorder (adhd).

clonidine is a centrally acting alpha2 adrenergic agonist that has been used effectively since the early 70s to treat mild to moderate hypertension. in addition to hypertension, clonidine has been evaluated and used extensively for several other indications, including attention deficit hyperactivity disorder (adhd). an easy to administer clonidine formulation is needed that retains the efficacy of the current oral formulation but has an improved safety profile. the current trial will investigate the safety and efficacy of clonidine delivered from the sustained release formulation of clonicel in the treatment of children and adolescents with adhd.

Eligibility criteria:
inclusion criteria: * male or female between 6 and 17 years of age, inclusive * diagnosis of adhd of the hyperactive or combined inattentive/hyperactive subtypes according to dsm-iv criteria * minimum score of 26 on the adhdrs-iv questionnaire at baseline * general good health as judged by the principal investigator * body mass index ≥ 5th percentile of the subject's age group according to the cdc growth chart. * ability to swallow tablets * general iq ≥80 as judged by the principal investigator * subject as well as parent/guardian able to sign informed assent or consent form. exclusion criteria: * if female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or iud * presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study. * presence of clinically significant abnormality on centrally interpreted electrocardiogram (ecg) readings * history or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant axis i or axis ii disorder that could interfere with study assessments in the judgment of the principal investigator * history of concomitant conduct disorder (cd) * history of seizures, except for a single episode of febrile seizure prior to age 2 * history of syncopal episodes * presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine * history of intolerance to clonidine, including any dermatologic reaction to transdermal clonidine * presence or history of alcohol or drug abuse * positive drug screen, with the exception of adhd drugs * use of any investigational drug within 30 days of study start.

Keywords: adhd clonidine attention deficit hyperactivity clonicel addrenex